Analyzing metabolic pathways in hormone receptor positive breast cancer
Official title: Pilot Study to Investigate the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
Run by Rutgers, The State University of New Jersey · NCT05736367 · Data updated 2026-11-12
This study tests how a special glucose infusion during breast cancer surgery can help researchers understand the metabolism of hormone receptor positive breast cancer to improve future treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | November 15, 2024 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2028 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT05736367 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with early-stage hormone receptor positive/HER2 negative breast cancer who are scheduled for surgical resection.
✕Probably not a fit
Patients with triple negative or HER2 positive breast cancer, as well as those currently enrolled in other clinical studies involving investigational therapies, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the metabolic activity of hormone receptor positive (HR+)/HER2 negative breast cancer by administering a U-13C-glucose infusion during routine breast cancer surgery. Participants will undergo tumor and blood sample collection to analyze the metabolic processes of the tumor. The study duration for each patient is three to four weeks, including a two to three hour glucose infusion and biopsy procedures. The goal is to gain insights into the tumor's metabolic behavior, which may inform future treatment strategies.
Why it matters
Potential benefit: If successful, this study could enhance understanding of breast cancer metabolism, potentially leading to more effective treatment options.
How similar studies have gone: While this approach is innovative, similar studies investigating metabolic pathways in cancer have shown promise, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have hormone receptor (HR) positive \[estrogen receptor( ER)+/progesterone receptor (PR)+, ER+/PR- or ER-/PR+)/Her2 negative breast cancer previously diagnosed by biopsy. * Have early stage, clinical or anatomic stage I, II or III breast cancer (cT1cN0, cT1cN1, cT2N0, cT2N1, cT3N0) * Candidates for intended curative primary resection who have not had neoadjuvant therapy (endocrine/hormonal therapy, chemotherapy with or without immunotherapy). * Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed surgical resection. Exclusion Criteria: * Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. * Has triple negative (ER-/PR-/Her2-) or HER2+ breast cancer. * Concomitant active malignancy * Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)
Where it's running
-
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States Recruiting -
RWJBarnabas Health
New Brunswick, New Jersey, United States Not yet recruiting
Study contacts
- Principal investigator: Coral Omene, MD, PhD — Cancer Institute of New Jersey Rutgers
- Study coordinator: Coral Omene, MD, PhD
- Email: co273@cinj.rutgers.edu
- Phone: 732-235-3374
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.